Product code KJH— Hematology

ACUSYST-JR

Classification name
Apparatus, Perfusion
Device class
Class 1
Regulation
21 CFR 864.2240
Advisory panel
Hematology
Total cleared
3
First cleared
Most recent

Market context for product code KJH

FDA has cleared 3 devices under product code KJH between 1986 and 1988, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code KJH

Recent clearances under product code KJH

Data sourced from openFDA. This site is unofficial and independent of the FDA.